Abdominal Massage With TENS on Parasacral Versus Sacral Area on Symptom,Severity & QOL in Chronic Constipation Females.

NCT06303011 | Completed DMC

• 1 other identifier: S22C14G92003
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Constipation is Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections. Patients complaining of constipation may mean different things by the term The frequency of their bowel actions may be less than 'normal', their stools maybe difficult to pass, or they may have a sense of malaise or abdominal discomfort which they attribute to a 'sluggish bowel', though the stool frequency and consistency are apparently normal. Objective of this study is to compare effects of Abdominal massage. withTENSonparasacralversussacralareaonsymptomseverityandqualityoflifein severechronicconstipationamongyoungfemales.

Conditions

Constipation

Keywords

Constipation; Quality of life; Abdominal massage

Outcome Measures

Primary Outcomes (2)

• PAC-SYM Questionnaire

  It is a self-reported questionnaire consisting of 12 symptoms divided into three domains: abdominal, rectal and stool, with responses rated on a. 5-point.The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire is frequently used in clinical trials of constipation. However, the threshold for reduction in total PAC-SYM score used to define a clinical response on this 0-4 point scale has not undergone formal appraisal, and its relationship with clinical benefit as perceived by patients has not been defined. PAC-SYM Questionnaire Validity is 0.68 to 0.72 and reliability is 0.75to 0.89

  8 weeks

• PAC-QOL Questionnaire

  The following questions are designed to measure the impact constipation has had on your daily life over the past 2 weeks. The overall PAC-QOL score consisted of four domains: physical discomfort, psycho- social discomfort, satisfaction, and worries and concerns. A lower score indicated a better outcome for symptomatic relief and QOL. PAC-QOL Questionnaire Validity is 0.76 to 3.41 and reliability is \>0.80.

  8 weeks

Study Arms (2)

Group: A

EXPERIMENTAL

TENS on sacral areas with Abdominal Massage

Other: Transcutaneous Electrical Nerve Stimulator

Group: B

ACTIVE COMPARATOR

TENS on para sacral area with Abdominal Massage

Other: TENS on para sacral area with Abdominal Massage

Interventions

Transcutaneous Electrical Nerve Stimulator OTHER

TENS will be applied on sacral and parasacral area. Frequency 10Hz, Pulse duration 200μs, Stimulation duration 20min

Group: A

TENS on para sacral area with Abdominal Massage OTHER

TENS on para sacral area with Abdominal Massage. Frequency 10Hz Pulse duration 200μs Stimulation duration 20min

Group: B

Eligibility Criteria

• Age: 14 Years - 35 Years
• Gender Eligibility Details: Females experience more constipation
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 14 -35year
• Only females
• Laxatives at least once or more for 2weeks
• Non pregnant
• Chronic Constipation more then 6 months

You may not qualify if:

• Organic dysphasia or secondary constipation caused by laxatives for unrelated conditions.
• Pregnant females suspected pregnant subjects, as well as those who were breast-feeding
• Non co-operative patients
• Female with underlying disease

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Faiza Taufiq, PPDPT

  Riphah International University, Senior Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: March 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)